Phase II trial of preoperatively CDDP/S-1 for patients with clinical stage II(exclusion N0 disease) and Stage IIIA non-small cell lung cancer

Phase II trial of preoperatively CDDP/S-1 for patients with clinical stage II(exclusion N0 disease) and Stage IIIA non-small cell lung cancer - Induction chemotherapy of CDDP/S-1 for patients with stage II or IIIA non-small cell lung cacer

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001928

Enrollment

Registered

2009-05-01

Start date

2008-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Preoperatively induction chemotherapy (CDDP/S-1)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histlogically confirmed non-small cell lung cancer 2)In principles, resectable stage II (exculde N0 disease) and stage IIIA patients by lobectomy, histologically or cytologically diagnosed N-factor using EBUS-TBNA 3)N2 disease without extra-nodal invasion 4)>=20, <75 years of age 4)feasible oral consumption 5)Performance statas 0 or 1 cases (ECOG scale) 6)Without previous therapy (operation, rdiotherapy, chemotherapy etc.) for non^small cell lung cancer 7)preserved organ's function within 2 weeks before registration. KL-6: normal WBC: more than 4000/m3 Neutorocytes: more than 2000/m3 Platelet: more than 100,000/m3 Hb: 9.0 more than g/dl AST(GOT), ALT(GPT): less than 100 IU/L T-bil: less than 1.5 md/dL PaO2: more than 70 Torr Ccr: 60mL/min [Cockcroft-Gault] male Ccr=body weight(BW)X(140-age)/(72 X serum Cre) female Ccr=BW X (140-age)/(72 X serum Cre)X 0.85 8)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with severe drug allergy 2)Patients with administration of another 5-fluouracil derivative drugs, flucytosine, phenytoin, warfarin sodium 3)Patients with active concomitant malignancy 4)Patients with active severe infection, diarrhea, interstinalparalysis, ileus, uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months from onset, heart failure, other severe complications 5)Patients with active lung disease such as idopathic pulmonary fibrosis, pulmonary emphysema, severe chronic bronchitis, bronchial asthma 6)Patients with uncontrollable psychiatrical complications

Design outcomes

Primary

Measure	Time frame
Analysis of regulation factors from lymph node samples usng EBUS-TBNA and relation to radiological, histological response rate after induction chemotherapy	—

Secondary

Measure	Time frame
feasibility, progression free survival, overall survival,and safety	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026